ArticleEuropean journal of clinical pharmacology2019
Adverse drug reaction causality assessment tools for drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis: room for improvement.
Article in European journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Photodistributed Stevens-Johnson syndrome and toxic epidermal necrolysis: a systematic review and proposal for a new diagnostic classification.European journal of medical research · 2023Pooled it
- Attribution of causality in Stevens-Johnson syndrome/toxic epidermal necrolysis.The ocular surface · 2025Review
- Liver Injury in Immune Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: Five New Classification Types.Journal of clinical and translational hepatology · 2025Review
- Update on Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: Diagnosis and Management.American journal of clinical dermatology · 2024Review
- Assessment of Need for Improved Identification of a Culprit Drug in Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis.JAMA dermatology · 2023Article
- Utilization of the Naranjo scale to evaluate adverse drug reactions at a free-standing children's hospital.PloS one · 2021Article
- Analysis of severity and preventability in patients of-Toxic epidermal necrolysis-A case series.Clinical case reports · 2020Article
- Adverse drug event presentation and tracking (ADEPT): semiautomated, high throughput pharmacovigilance using real-world data.JAMIA open · 2020Article
- Pediatric SJS-TEN: Where are we now?F1000Research · 2020Review
- Strategies for Clarifying Penicillin Allergies When Skin Testing Is Not an Option.Pharmacy (Basel, Switzerland) · 2019Review
- SJS/TEN 2017: Building Multidisciplinary Networks to Drive Science and Translation.The journal of allergy and clinical immunology. In practiceReview
- Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Associated with Carbonic Anhydrase Inhibitors: Epidemiology, Genetics, and Insights into Mechanisms.The journal of allergy and clinical immunology. In practiceArticle
Corrections and comments
- Erratum issued
Authors and funding
12 authors.
Funding
Abstract
purposeEstablishment of causality between drug exposure and adverse drug reactions (ADR) is challenging even for serious ADRs such as Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN). Several causality assessment tools (CAT) exist, but the reliability and validity of such tools is variable. The objective of this study was to compare the reliability and validity of existing ADR CATs on SJS/TEN cases.
methodsSeven investigators completed three CAT (ALDEN, Naranjo, Liverpool) for 10 SJS/TEN cases. Each CAT categorized the causality of 30 potential drugs as definite/very probable, probable, possible, or doubtful/unlikely. An additional reviewer provided expert opinion by designating the implicated drug(s) for each case. A Kappa score was generated to compare CAT responses both by method (reliability of all 7 reviewers, by CATs) and by reviewer (reliability of the 3 CAT, by reviewer). A c statistic was calculated to assess validity.
resultsInter-rater reliability by CAT was poor to fair: ALDEN 0.22, Naranjo 0.11, and Liverpool 0.12. Reliability was highest when causality classification was definite/very probable (0.16-0.41). Similarly, intra-rater reliability by reviewer was poor. When comparing the validity of the overall CAT to expert reviewer, area under the curve was highest for ALDEN (c statistic 0.65) as compared to Liverpool (0.55) or Naranjo (0.54).
conclusionAvailable CAT have poor reliability and validity for drug-induced SJS/TEN. Due to the importance of determining ADR causality for research, industry, and regulatory purposes, development of an enhanced tool that can incorporate data from immunological testing and pharmacogenetic results may strengthen CAT usefulness and applicability for drug-induced SJS/TEN.
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